Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Rebecca Lewis


Contact details

Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
United Kingdom
+44 (0)20 8722 4081

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

2x2 factorial randomised phase III study comparing standard versus whole bladder volume radiotherapy with and without synchronous chemotherapy in muscle invasive bladder cancer


Study hypothesis

Added 31/05/2011:
Study hypothesis: BC2001 is a multi-centred randomised controlled trial which aims:
1. To investigate the efficacy and toxicity of synchronous chemo-radiotherapy in conservative management of invasive bladder cancer compared to radiotherapy alone.
2. To investigate whether modifying the volume of bladder irradiated by the full dose of radiotherapy can reduce toxicity of radiotherapy in the conservative treatment of invasive bladder cancer, without impacting on local control.

Ethics approval

North West 5 Research Ethics Committee, 05/03/2001, ref: MREC 00/8/075

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Bladder (advanced)


Four possible randomisations as follows:
1. Synchronous 5-Fluorouracil (5-FU) and Mitomycin with standard radiotherapy (to the whole bladder)
2. Synchronous 5-FU and Mitomycin with whole bladder volume radiotherapy
3. Standard radiotherapy to the whole bladder and no chemotherapy
4. Whole bladder volume radiotherapy and no chemotherapy

Intervention type



Drug names

Primary outcome measure

Added 02/06/2011:
Loco-regional (Ui.e. pelvic nodes & bladderU) disease free survival. The particular time point of interest is 2 years post randomisation

Secondary outcome measures

Secondary endpoint:
Disease free survival, Metastases free survival, Late toxicity at 1 and 2 years as assessed by RTOG and Lent Som toxicity scores, bladder capacity and Fact-BL QoL score. This endpoint is of particular importance in the radiotherapy comparison.

Tertiary endpoints:
1. Acute toxicity
2. Cystoscopic local control at 6 months, 1 year and 2 years post randomisation
3. Rate of salvage cystectomy
4. Overall survival

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Aged 18 or over
2. Histologically proven invasive bladder carcinoma (adenocarcinoma, transitional or squamous cell carcinoma)
3. Localised muscle invasive carcinoma either surgically or by imaging (T2-T4a, N0, M0)
4. Patients with multiple tumours at the time of randomisation are not eligible for the radiotherapy volume randomisation but may be randomised to whole bladder radiotherapy with or without chemotherapy
5. World Health Organisation (WHO) performance status 0-2 Leucocytes >4.0 x 10(9)/ l; Platelets >100 x 10(9)/l Glomerular filtration rate (GFR) >25 ml/min Serum bilirubin <1.5 upper limit of reference range (ULRR) alanine amino transferase (ALT) or aspartate amino transferase (AST) <1.5 x ULRR
6. Patient available for long term follow up and in the opinion of the investigator, able to receive radical radiotherapy
7. Patients written informed consent
8. Able to understand and complete the QoL questionnaire (patient can enter study without QoL but ALL are invited)

Participant type


Age group




Target number of participants

350 (Added 02/06/2011)

Participant exclusion criteria

1. Uncontrolled systemic disease which would preclude the patient from the study
2. Pregnancy
3. Other malignancy within the previous 2 years (other than adequately treated BCC of the skin or adequately treated in situ carcinoma of the cervix uteri)
4. Previous malignancy that is likely to interfere with protocol treatment
5. Inflammatory bowel disease
6. Previous pelvic radiotherapy
7. Bilateral hip replacements compromising accurate radiotherapy planning

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
United Kingdom

Sponsor information


Individual Sponsor (UK)

Sponsor details

Prof Nick James
Queen Elizabeth Hospital
Clinical Trials Unit
B15 2TH
United Kingdom
+44 (0)121 414 4097

Sponsor type




Funder type


Funder name

Cancer Research UK

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2012 results in:
2. 2013 results in:
3. 2015 results in:

Publication citations

  1. Results

    James ND, Hussain SA, Hall E, Jenkins P, Tremlett J, Rawlings C, Crundwell M, Sizer B, Sreenivasan T, Hendron C, Lewis R, Waters R, Huddart RA, , Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer., N. Engl. J. Med., 2012, 366, 16, 1477-1488, doi: 10.1056/NEJMoa1106106.

  2. Results

    Huddart RA, Hall E, Hussain SA, Jenkins P, Rawlings C, Tremlett J, Crundwell M, Adab FA, Sheehan D, Syndikus I, Hendron C, Lewis R, Waters R, James ND, Randomized noninferiority trial of reduced high-dose volume versus standard volume radiation therapy for muscle-invasive bladder cancer: results of the BC2001 trial (CRUK/01/004)., Int. J. Radiat. Oncol. Biol. Phys., 2013, 87, 2, 261-269, doi: 10.1016/j.ijrobp.2013.06.2044.

  3. Results

    McDonald F, Waters R, Gulliford S, Hall E, James N, Huddart RA, Defining bowel dose volume constraints for bladder radiotherapy treatment planning, Clin Oncol (R Coll Radiol), 2015, 27, 1, 22-29, doi: 10.1016/j.clon.2014.09.016.

Additional files

Editorial Notes

17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)